Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance

Health and Quality of Life Outcomes

Brian Bekker Hansen²  Martin Strandberg-Larsen²  Lise Højbjerre²  Helen Kitchen³  Claire Pilling¹  Louise Heron¹  Louise Humphrey⁴  Laura Holloway¹ 

[1] Adelphi Values, Adelphi Mill, Bollington, Macclesfield SK10 5JB, Cheshire, UK;Novo Nordisk A/S, Novo Allé 1, Bagsvaerd, 2880, Denmark;The University of Manchester, Oxford Road, Manchester M13 9PL, UK;Abacus International, Manchester One, Manchester M1 3LD, UK

关键词: Health-related quality of life;    Fatigue;    Conceptual model;    Patient-reported outcomes;    Systemic lupus erythematosus;   

Others  :  1164559
DOI  :  10.1186/s12955-014-0116-1

 received in 2014-03-10, accepted in 2014-07-08,  发布年份 2014

【 摘 要 】

Background

Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials.

Methods

A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials.

Results

The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and Activity Impairment Questionnaire: Lupus (WPAI:Lupus) showed suitability for SLE economic models.

Conclusions

Based on the identification of key symptoms and impacts of SLE using a scientifically sound conceptual model, we conclude that SLE is a condition associated with high unmet need and considerable burden to patients. This review highlights the availability and need for disease-specific and generic patient-reported measures of relevant domains of disease signs and symptoms, HRQoL and work productivity, providing useful insight for SLE clinical trial design.

【 授权许可】

   
2014 Holloway et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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